- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07573761
Evaluation of the Effectiveness of Odontogenic Grafts Obtained From Human Teeth on Bone Formation
Socket Preservation and Odontogenic Graft Obtained From Human Tooth
Tooth extraction triggers a cascade of biological events mediated by the local inflammatory response following surgical intervention and by the loss of masticatory stimulation to the periodontium. These factors disrupt the homeostasis and structural integrity of the periodontal tissues. Following tooth loss, bone remodeling is initiated and continues for several months, with the majority of dimensional and morphological changes occurring within the first three months. This early alveolar bone resorption may compromise future implant placement and prosthetic rehabilitation.
Previous studies by Schmidt-Schultz and Schultz have demonstrated that biologically intact growth factors can be preserved within the collagenous extracellular matrix of ancient human bone and teeth. These findings suggest that stored dentin may retain biologically active growth factors and provide regenerative benefits comparable to those of freshly prepared dentin, while eliminating the need for simultaneous multiple surgical interventions. Moreover, the volume of particulate dentin exceeds twice the original root volume, allowing for the acquisition of sufficient graft material for clinical application.
Based on these biological and volumetric advantages, the use of autogenous stored mineralized dentin grafts (ASMDG) has emerged as a promising approach for alveolar socket preservation. ASMDG may contribute to limiting post-extraction alveolar ridge resorption and maintaining ridge dimensions during the critical early healing period.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Uskudar
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Istanbul, Uskudar, 터키 (Türkiye), 34668
- Health Sciences University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients requiring tooth extraction due to periodontal reasons (teeth with a hopeless prognosis), root caries, or root fractures, who are simultaneously candidates for posterior replacement with an osseointegrated implant, and who require extraction of at least two teeth.
- Integrity of the alveolar socket walls following tooth extraction.
- Patients who accept the study conditions, sign written informed consent, and agree to attend the scheduled follow-up visits.
Exclusion Criteria:
- General contraindications for dental and/or surgical treatments.
- Inflammatory or autoimmune diseases of the oral cavity.
- Uncontrolled diabetes mellitus (HbA1c > 7%).
- History of malignancy requiring chemotherapy or radiotherapy within the past 5 years.
- Previous treatment with immunosuppressive agents, bisphosphonates, or high-dose corticosteroids.
- Smoking more than 10 cigarettes per day.
- Pregnant or breastfeeding women.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Study Group
Dentin graft socket preservation
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Control Group
Spontaneous healing
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean change in horizontal alveolar ridge width (mm) from baseline to 4 months (CBCT)
기간: Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)
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Horizontal alveolar ridge width will be measured in millimeters using cone-beam computed tomography (CBCT) at baseline (immediately after tooth extraction) and at 4 months postoperatively prior to implant placement. The primary outcome will be defined as the mean change in ridge width (Δ width = width at 4 months - width at baseline), expressed in millimeters. |
Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean change in vertical alveolar ridge height (mm) from baseline to 4 months (CBCT)
기간: Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)
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Vertical alveolar ridge height will be measured in millimeters using cone-beam computed tomography (CBCT) at baseline (immediately after tooth extraction) and at 4 months postoperatively prior to implant placement. The secondary outcome will be defined as the mean change in ridge height (Δ height = height at 4 months - height at baseline), expressed in millimeters. |
Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .